Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Completed · Phase 2

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.

Key facts

Study ID

NCT00262405

Run by

University of Michigan

People needed

44

Starts

2001-01-01

Expected to finish

2007-05-01

Last updated by the study team

2015-12-03

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic pulmonary fibrosis
• Taking < 15 mg prednisone for at least 30 days prior to screening
• Age 35-80, inclusive
• Able to understand a written informed consent and comply with the study protocol

You may not qualify if…

• Significant environmental exposure
• Diagnosis of collagen vascular disease
• Evidence of active infection
• Clinically significant cardiac disease Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia
• Poorly controlled or severe diabetes mellitus
• Pregnancy or lactation
• Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
• Current enrollment in another experimental protocol
• Physiologic Criteria:
• FEV1/FVC < 0.60
• Laboratory Criteria:
• Total bilirubin > 1.5 X upper limit normal
• AST or ALT > 3X upper limit normal
• Alkaline phosphatase > 3X upper limit normal
• White blood cell count < 2,500/mm3
• Hematocrit < 30%
• Platelets < 100,000/mm3
• Prothrombin time INR > 1.5

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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